Two root canal techniques for postoperative pain and neuropeptide levels
Impact Of Manual-Less Root Canal Instrumentation Versus Conventional Rotary Instrumentation On Post Operative Pain And Level Of Neuropeptides: Randomized Controlled Clinical Trial
This trial will test whether a manual-less rotary approach to root canal treatment causes less postoperative pain and different levels of substance P and CGRP than the conventional rotary method in adults with symptomatic irreversible pulpitis of mandibular molars.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria) |
| Trial ID | NCT07357233 on ClinicalTrials.gov |
What this trial studies
In this single-center randomized trial, 34 mandibular molars with symptomatic irreversible pulpitis and apical periodontitis will be allocated 1:1 to a manual-less rotary instrumentation protocol or a conventional rotary protocol that includes hand-file scouting and glide path creation. Treatment time and postoperative pain (numeric rating scale) will be recorded, and levels of substance P and CGRP in periapical samples will be measured by ELISA before and after instrumentation. The trial compares clinical pain outcomes with objective neuropeptide changes to explore correlations between procedure, debris extrusion risk, and pain signaling. All participants will be healthy adults aged 18–50 treated at Alexandria Faculty of Dentistry under standardized anesthesia and protocol conditions.
Who should consider this trial
Good fit: Adults aged 18–50 with symptomatic irreversible pulpitis and apical periodontitis in mandibular molars, good oral hygiene, closed apices, and classified ASA I are ideal candidates.
Not a fit: Patients who are pregnant, currently taking analgesics, have unrestorable teeth, root resorption or abnormal root anatomy, or who cannot tolerate standard endodontic care are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could shorten treatment time and reduce postoperative pain after root canal procedures.
How similar studies have performed: Rotary NiTi systems and controlled-memory files have previously reduced preparation time and debris extrusion, but a fully manual-less technique specifically tested for postoperative neuropeptide changes is relatively novel and not widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with symptomatic irreversible pulpitis and apical periodontitis in mandibular molars with closed apex.(17) 2. Healthy males and females (Category: American Society of Anesthesiologists class I). 3. Age of patients range from 18 to 50 years old. 4. Those who could understand the use of the numeric rating scale (NRS) for pain. 5. In cases where radiographs show no root resorption or abnormal anatomy. 6. Patients with good oral hygiene and free from periodontal diseases. Exclusion Criteria: 1. Allergy to anesthetics. 2. Pregnancy 3. Unrestorable teeth. 4. Patient on analgesics. 5. Prescence of root resorption or abnormal anatomy.
Where this trial is running
Alexandria
- Alexandria Faculty of Dentistry — Alexandria, Egypt (Recruiting)
Study contacts
- Study coordinator: hamdy Abou Almakarem, Msc
- Email: hamdy.elwan.dent@alexu.edu.eg
- Phone: 01273805931
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.